BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver

By Donald Zuhn --

Yesterday, United States Trade Representative Katherine Tai announced "the Biden-Harris Administration's support for waiving intellectual property protections for COVID-19 vaccines" (see "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines").  The waiver was proposed last fall by India and South Africa, which asked the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) to recommend "a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19" to the General Council of the WTO.  In March, the Biotechnology Innovation Organization (BIO), a group of fifteen industry and trade organizations (including BIO), and a group of intellectual property organizations (including the IPO), sent letters to the Biden Administration, members of Congress, and officials at the Patent and Copyright Offices asking the recipients to oppose the waiver proposal.

In response to Ambassador Kai's statement on Wednesday, BIO and IPO released their own statements.  BIO's statement, which was issued by BIO's president and CEO, Dr. Michelle McMurry-Heath, noted that the organization was "extremely disappointed that the Administration has chosen to support waiving critical protections for American ingenuity and to delay the equitable delivery of needed COVID vaccines to people around the globe."  Dr. McMurry-Heath explained that:

Handing needy countries a recipe book without the ingredients, safeguards, and sizable workforce needed will not help people waiting for the vaccine.  Handing them the blueprint to construct a kitchen that -- in optimal conditions -- can take a year to build will not help us stop the emergence of dangerous new COVID variants.  The better alternative would have been to follow through on the President's pledge just last week to make the United States the world's "arsenal of vaccines".  This policy leads in the opposite direction.

BIO pointed to the COVID Global Strategy for Harnessing Access Reaching Everyone (SHARE) Program as a better alternative to "ensure sufficient global supply of vaccines, ensure safe and expeditious global access to vaccines and therapeutics, and bolster ongoing efforts to strengthen and support healthcare systems in low-and middle-income countries in addressing COVID."  BIO also contended that the Administration's "decision will disadvantage patients by undermining existing incentives to develop vaccines and therapeutics for future pandemics."  BIO concluded by stating that:

The United States has unfortunately chosen to set a dangerous precedent with these actions.  But how we negotiate with the WTO moving forward will be critical in mitigating this myopic decision and its effects on patients around the world.

IPO Executive Director Jessica Landacre stated that the organization was "extremely disappointed by the U.S. government's statement yesterday that it will support 'waiving intellectual property protections for COVID-19 vaccines.'"  She noted that the IPO "supports equitable, widespread, and successful distribution of vaccines to meet the challenges of COVID-19, but waiving IP rights would not further this goal," adding that "should a waiver of IP rights be implemented, it would have an immediate chilling effect on the research and collaborations that are needed to continue to combat COVID-19 and that will be needed to tackle any future crisis."  The IPO believes that the Administration's decision "sets a dangerous precedent," and contends that the "misinformed approach" will "not solve the problem it seeks to address."

The Biden Administration's decision to support a waiver of IP protections for COVID-19 vaccines, and the response to that decision, raises the question of how the ongoing humanitarian crisis in India can be most quickly addressed.  In a May 1 article in MIT Technology Review, Krishna Udayakumar and Andrea Taylor of the Duke Global Health Innovation Center write that "immediate and aggressive measures are needed to stabilize the situation and buy time for vaccine production to ramp up" (see "What India Needs to Get Through Its Covid Crisis").  They note that the crisis "will require coordinated global action."  In particular, India requires medical oxygen, medications, hospital beds, ventilators, personal protective equipment, COVID testing supplies, and more health workers "to augment India's own, who are currently working under immense pressure."  While the authors note that the first aid shipments from the UK and the U.S. arrived on April 27 and 30, respectively, they indicate that "[e]ven this global aid response will not avert a historic tragedy."  The authors conclude the article by stating that:

The heartbreaking tragedy in India will unfortunately continue for many weeks.  But by mobilizing global resources more quickly, adopting public health measures that will keep the virus in check, and ramping up vaccine manufacturing, India and the global community can at least offer some hope of better days ahead.

For additional information regarding this topic, please see:

• "Biden Administration Supports Waiver of IP Protection for COVID-19 Vaccines," May 5, 2021
• "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals)," April 26, 2021
• "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal," April 21, 2021
• "IP Organizations Support Continued Opposition to Waiver Proposal," April 5, 2021
• "Industry Coalition Supports Continued Efforts to Oppose Waiver Proposal," March 29, 2021
• "BIO and PhRMA Urge Biden Administration to Oppose Proposed WTO TRIPS Waiver," March 11, 2021
• "IPO Sends Letter on IP Law and Policy to President-Elect and Vice President-Elect," January 4, 2021

Comments

[Greg DeLassus]

"The IPO believes that the Administration's decision 'sets a dangerous precedent,' and contends that the 'misinformed approach' will 'not solve the problem it seeks to address.'"

I can certainly agree that the waiver that eventually emerges will not solve any real problems. It is an empty gesture---nothing more than a PR move, really.

Precisely because of its hollowness, however, I am not convinced that it is any sort of "dangerous precedent." It is only as "dangerous" as we make it to be. IPO does not *have* to characterize this as the start down a slippery slope. There is a perfectly fine argument to be made that the COVID19 pandemic is a once-in-a-lifetime *exceptional* circumstance, and that actions taken in response to this exceptional circumstance are an *exception*, not a new normal. We really do ourselves no favors by characterizing this in a way that makes the public *think* of the waiver as a precedent.

[skeptical]

A FIRST EVER instance is somehow to be viewed as having zero possible effect on precedent....?

Yes, that Reverse Tinkerbell effect is called to mind.

(and no, I know of no one that is actually holding the strawman position that somehow 'this' is a New Normal)

Now granted, mind you, it IS a fair question as to what possible next calamity might rise to a (at this point undetermined) standard that would invoke ANOTHER exception. There are of course MANY items that cause death world-wide, and some may even want to play a type of "Equity" card to elevate other matters to be considered for any such "NEW" standard for invoking (multiple, or multiply different) levels of IP waiver.